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1. Full Text Adverse Event Reporting in Cancer Clinical Trial Publications
by Shanthi Sivendran and Asma Latif and Russell B. McBride and Kristian D. Stensland and Juan Wisnivesky and Lindsay Haines and William K. Oh and Matthew D. Galsky
Journal of Clinical Oncology, ISSN 0732-183X, 01/2014, Volume 32, Issue 2, pp. 83 - 89
Purpose Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group... 
RANDOMIZED CONTROLLED-TRIALS | METAANALYSIS | QUALITY | ONCOLOGY | RECOMMENDATIONS | BEVACIZUMAB | CONSORT STATEMENT | HARMS | Clinical Trials, Phase III as Topic - standards | Adverse Drug Reaction Reporting Systems - standards | Humans | Linear Models | Publications - standards | Research Report - standards | Neoplasms - drug therapy | Randomized Controlled Trials as Topic - standards
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2. Full Text Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial
by Stupp, Roger and Taillibert, Sophie and Kanner, Andrew A and Kesari, Santosh and Steinberg, David M and Toms, Steven A and Taylor, Lynne P and Lieberman, Frank and Silvani, Antonio and Fink, Karen L and Barnett, Gene H and Zhu, Jay-Jiguang and Henson, John W and Engelhard, Herbert H and Chen, Thomas C and Tran, David D and Sroubek, Jan and Tran, Nam D and Hottinger, Andreas F and Landolfi, Joseph and Desai, Rajiv and Caroli, Manuela and Kew, Yvonne and Honnorat, Jerome and Idbaih, Ahmed and Kirson, Eilon D and Weinberg, Uri and Palti, Yoram and Hegi, Monika E and Ram, Zvi
JAMA, ISSN 0098-7484, 12/2015, Volume 314, Issue 23, pp. 2535 - 2543
IMPORTANCE: Glioblastoma is the most devastating primary malignancy of the central nervous system in adults. Most patients die within 1 to 2 years of... 
PHASE-III TRIAL | ALTERNATING ELECTRIC-FIELDS | NOVOTTF-100A | MEDICINE, GENERAL & INTERNAL | TREATMENT MODALITY | NEWLY-DIAGNOSED GLIOBLASTOMA | RECURRENT GLIOBLASTOMA | OPEN-LABEL | QUALITY-OF-LIFE | RADIOTHERAPY | ADJUVANT TEMOZOLOMIDE | Dacarbazine - therapeutic use | United States | Humans | Middle Aged | Male | Chemoradiotherapy | Young Adult | Early Termination of Clinical Trials | Carmustine - therapeutic use | Maintenance Chemotherapy - methods | Dacarbazine - analogs & derivatives | Aged, 80 and over | Adult | Female | Brain Neoplasms - mortality | Republic of Korea | Europe | Combined Modality Therapy - adverse effects | Disease Progression | Antineoplastic Agents, Alkylating - therapeutic use | Glioblastoma - therapy | Canada | Disease-Free Survival | Electric Stimulation Therapy - methods | Electric Stimulation Therapy - adverse effects | Brain Neoplasms - therapy | Aged | Combined Modality Therapy - methods | Israel | Glioblastoma - mortality | Patient safety | Brain cancer | Medical treatment | Analysis
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3. Full Text Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial
by Stupp, Roger and Taillibert, Sophie and Kanner, Andrew and Read, William and Steinberg, David M and Lhermitte, Benoit and Toms, Steven and Idbaih, Ahmed and Ahluwalia, Manmeet S and Fink, Karen and Di Meco, Francesco and Lieberman, Frank and Zhu, Jay-Jiguang and Stragliotto, Giuseppe and Tran, David D and Brem, Steven and Hottinger, Andreas F and Kirson, Eilon D and Lavy-Shahaf, Gitit and Weinberg, Uri and Kim, Chae-Yong and Paek, Sun-Ha and Nicholas, Garth and Bruna, Jordi and Hirte, Hal and Weller, Michael and Palti, Yoram and Hegi, Monika E and Ram, Zvi
JAMA, ISSN 0098-7484, 12/2017, Volume 318, Issue 23, pp. 2306 - 2316
IMPORTANCE: Tumor-treating fields (TTFields) is an antimitotic treatment modality that interferes with glioblastoma cell division and organelle assembly by... 
PHASE-III TRIAL | MALIGNANT GLIOMA | MEDICINE, GENERAL & INTERNAL | BEVACIZUMAB | NEWLY-DIAGNOSED GLIOBLASTOMA | CENTRAL-NERVOUS-SYSTEM | OPEN-LABEL | QUALITY-OF-LIFE | RADIOTHERAPY | BRAIN | ADJUVANT TEMOZOLOMIDE | Dacarbazine - adverse effects | Follow-Up Studies | Dacarbazine - therapeutic use | Mitosis | Humans | Middle Aged | Male | Electric Stimulation Therapy | Chemoradiotherapy | Glioblastoma - radiotherapy | Glioblastoma - surgery | Antineoplastic Agents, Alkylating - therapeutic use | Disease-Free Survival | Dacarbazine - analogs & derivatives | Survival Analysis | Adult | Female | Aged | Maintenance Chemotherapy | Temozolomide | Antineoplastic Agents, Alkylating - adverse effects | Glioblastoma - drug therapy | Chemotherapy | Usage | Patient outcomes | Dosage and administration | Drug therapy | Glioblastoma multiforme | Cancer | Statistical analysis | Toxicity | Glioblastoma | Central nervous system | Clinical trials | Cell division | Nervous system | Maintenance | Patients | Survival | Randomization | Scalp | Skin | Portable equipment | Electric fields | Tumors | Original Investigation | Research
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4. Full Text Summary of Ceftaroline Fosamil Clinical Trial Studies and Clinical Safety
by Thomas M. File and Mark H. Wilcox and Gary E. Stein
Clinical Infectious Diseases, ISSN 1058-4838, 9/2012, Volume 55, Issue 3, pp. S173 - S180
In October 2010, the new cephalosporin, ceftaroline fosamil, was approved by the US Food and Drug Administration for therapy of community-acquired bacterial... 
Pathogens | Pneumonia | Cephalosporins | Antimicrobials | Bacterial pneumonia | Clinical trials | Infections | Skin | Medical cures | Staphylococcus aureus | INFECTIOUS DISEASES | COMMUNITY-ACQUIRED PNEUMONIA | MULTICENTER | INFECTIONS | CEFTRIAXONE | PHASE-III | MICROBIOLOGY | IMMUNOLOGY | RESISTANT STAPHYLOCOCCUS-AUREUS | COMPLICATED SKIN | CANVAS 1 | DOUBLE-BLIND | INTEGRATED ANALYSIS | Cephalosporins - therapeutic use | Anti-Bacterial Agents - therapeutic use | Staphylococcal Skin Infections - drug therapy | Humans | Pneumonia, Bacterial - drug therapy | Anti-Bacterial Agents - adverse effects | Clinical Trials as Topic | Cephalosporins - adverse effects
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5. Full Text Lessons Learned From a "Failed" Clinical Trial
by Leijten, EFA and Radstake, TRDJ and Reedquist, KA
ARTHRITIS & RHEUMATOLOGY, ISSN 2326-5191, 09/2018, Volume 70, Issue 9, pp. 1364 - 1365
SPLEEN TYROSINE KINASE | MULTICENTER | DISEASES | FOSTAMATINIB | INADEQUATE RESPONSE | PARALLEL-GROUP | PHASE-III | DOUBLE-BLIND | RHEUMATOLOGY | INHIBITOR | RHEUMATOID-ARTHRITIS PATIENTS
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6. Full Text Clinical Trial Designs for Predictive Biomarker Validation: Theoretical Considerations and Practical Challenges
by Sumithra J. Mandrekar and Daniel J. Sargent
Journal of Clinical Oncology, ISSN 0732-183X, 08/2009, Volume 27, Issue 24, pp. 4027 - 4034
Purpose Biomarkers can add substantial value to current medical practice by providing an integrated approach to prediction using the genetic makeup of the... 
CELL LUNG-CANCER | POSITIVE BREAST-CANCER | ADJUVANT CHEMOTHERAPY | GROWTH-FACTOR RECEPTOR | SURVIVAL BENEFIT | ONCOLOGY | COLORECTAL-CANCER | PHASE-III | MINDACT TRIAL | GENE COPY NUMBER | GEFITINIB IRESSA | Clinical Trials as Topic | Retrospective Studies | Prospective Studies | Biomarkers, Tumor | Research Design | Humans | To2 | Bios3 | Statistics in Oncology
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7. Full Text Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial
by Brown, Paul D and Jaeckle, Kurt and Ballman, Karla V and Farace, Elana and Cerhan, Jane H and Anderson, S. Keith and Carrero, Xiomara W and Barker, Fred G and Deming, Richard and Burri, Stuart H and Ménard, Cynthia and Chung, Caroline and Stieber, Volker W and Pollock, Bruce E and Galanis, Evanthia and Buckner, Jan C and Asher, Anthony L
JAMA, ISSN 0098-7484, 07/2016, Volume 316, Issue 4, pp. 401 - 409
IMPORTANCE: Whole brain radiotherapy (WBRT) significantly improves tumor control in the brain after stereotactic radiosurgery (SRS), yet because of its... 
PHASE-III TRIAL | MEDICINE, GENERAL & INTERNAL | STEREOTACTIC RADIOSURGERY | NEUROCOGNITIVE FUNCTION | QUALITY-OF-LIFE | SURGICAL RESECTION | RADIOTHERAPY | CANCER | TUMORS | Humans | Middle Aged | Radiosurgery | Survivors | Male | Cranial Irradiation | Brain Neoplasms - surgery | Brain Neoplasms - secondary | Time Factors | Cognition Disorders - etiology | Survival Analysis | Quality of Life | Adult | Dose Fractionation | Female | Aged | Combined Modality Therapy - methods | Brain Neoplasms - mortality | Brain Neoplasms - radiotherapy | Cognition - radiation effects | Complications and side effects | Brain | Usage | Analysis | Clinical trials | Radiotherapy | Health aspects | Metastasis | Radiation therapy | Brain cancer | Quality of life
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8. Full Text The Next Generation of Sepsis Clinical Trial Designs: What Is Next After the Demise of Recombinant Human Activated Protein C?
by Opal, Steven M and Dellinger, R Phillip and Vincent, Jean-Louis and Masur, Henry and Angus, Derek C
Critical Care Medicine, ISSN 0090-3493, 07/2014, Volume 42, Issue 7, pp. 1714 - 1721
OBJECTIVE:The developmental pipeline for novel therapeutics to treat sepsis has diminished to a trickle compared to previous years of sepsis research. While... 
clinical trial design | tumor necrosis factor antibody | septic shock | severe sepsis | sepsis | intensive care units | MULTICENTER | EFFICACY | SAFETY | INTERLEUKIN-1 RECEPTOR ANTAGONIST | PHASE-III | TUMOR-NECROSIS-FACTOR | DOUBLE-BLIND | SURVIVING SEPSIS | THERAPIES | CRITICAL CARE MEDICINE | Recombinant Proteins - therapeutic use | Drug Evaluation, Preclinical - methods | Sepsis - drug therapy | Fibrinolytic Agents - therapeutic use | Humans | Biomarkers | Clinical Trials, Phase II as Topic - methods | Research Design | Protein C - therapeutic use | Clinical Trials, Phase III as Topic - methods
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9. Full Text A randomized clinical trial of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the oesophagus or gastro-oesophageal junction
by Klevebro, F and von Döbeln, G. Alexandersson and Wang, N and Johnsen, G and Jacobsen, A.-B and Friesland, S and Hatlevoll, I and Glenjen, N.I and Lind, P and Tsai, J.A and Lundell, L and Nilsson, M
Annals of Oncology, ISSN 0923-7534, 04/2016, Volume 27, Issue 4, pp. 660 - 667
Neoadjuvant chemoradiotherapy gives increased local tumour control compared with neoadjuvant chemotherapy, without significantly affecting survival in... 
Chemotherapy | Chemoradiotherapy | Neoadjuvant treatment | Oesophageal carcinoma | SURGERY | SURVIVAL | oesophageal carcinoma | PERIOPERATIVE CHEMOTHERAPY | METAANALYSIS | ADENOCARCINOMA | chemoradiotherapy | chemotherapy | neoadjuvant treatment | PHASE-III TRIAL | ONCOLOGY | CHEMORADIATION | ESOPHAGOGASTRIC JUNCTION | RESECTABLE ESOPHAGEAL | SQUAMOUS-CELL CANCER | Adenocarcinoma - pathology | Humans | Middle Aged | Esophagogastric Junction - pathology | Male | Treatment Outcome | Lymphatic Metastasis | Adenocarcinoma - drug therapy | Remission Induction | Esophageal Neoplasms - pathology | Disease-Free Survival | Sweden | Fluorouracil - administration & dosage | Esophagogastric Junction - surgery | Esophageal Neoplasms - surgery | Norway | Adult | Female | Neoadjuvant Therapy | Aged | Neoplasm Staging | Esophageal Neoplasms - drug therapy | Adenocarcinoma - surgery
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10. Full Text Women on multiple sclerosis clinical trial steering committees
by Moneim, Joseph and Coles, Alasdair and Giovannoni, Gavin and Horne, Rachel and Carr, Oliver
Annals of Neurology, ISSN 0364-5134, 08/2018, Volume 84, Issue 2, pp. 329 - 330
NEUROSCIENCES | CLINICAL NEUROLOGY | Committee Membership | Clinical Trials, Phase III as Topic - standards | Multiple Sclerosis - diagnosis | Sexism - trends | Humans | Female | Authorship - standards | Multiple Sclerosis - therapy | Clinical Trials, Phase III as Topic - methods | Clinical trials | Multiple sclerosis
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11. Full Text Pilot clinical trial of hedgehog pathway inhibitor GDC-0449 (vismodegib) in combination with gemcitabine in patients with metastatic pancreatic adenocarcinoma
by Kim, Edward J and Sahai, Vaibhav and Abel, Ethan V and Griffith, Kent A and Greenson, Joel K and Takebe, Naoko and Khan, Gazala N and Blau, John L and Craig, Ronald and Balis, Ulysses G and Zalupski, Mark M and Simeone, Diane M
Clinical Cancer Research, ISSN 1078-0432, 12/2014, Volume 20, Issue 23, pp. 5937 - 5945
Purpose: The hedgehog (HH) signaling pathway is a key regulator in tumorigenesis of pancreatic adenocarcinoma and is upregulated in pancreatic adenocarcinoma... 
PHASE-III TRIAL | PLUS GEMCITABINE | SURVIVAL | 1ST-LINE TREATMENT | ONCOLOGY-GROUP | THERAPY | ONCOLOGY | DUCTAL ADENOCARCINOMA | STROMA | CANCER | Adenocarcinoma - pathology | Humans | Middle Aged | Antineoplastic Combined Chemotherapy Protocols - adverse effects | Hedgehog Proteins - metabolism | Male | Pancreatic Neoplasms - drug therapy | Neoplasm Metastasis | Neoplastic Stem Cells - metabolism | Aged, 80 and over | Female | Pancreatic Neoplasms - mortality | Biomarkers - metabolism | Pyridines - administration & dosage | Deoxycytidine - administration & dosage | Pancreatic Neoplasms - pathology | Treatment Outcome | Adenocarcinoma - drug therapy | Anilides - administration & dosage | Signal Transduction - drug effects | Antineoplastic Combined Chemotherapy Protocols - therapeutic use | Biopsy | Aged | Deoxycytidine - analogs & derivatives | Adenocarcinoma - mortality | GDC-0449 | stem cells | hedgehog | SMO | PTCH1 | fibrosis | GLI1
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12. Full Text Omics-based clinical trial designs
by Buyse, Marc and Michiels, Stefan
Current Opinion in Oncology, ISSN 1040-8746, 05/2013, Volume 25, Issue 3, pp. 289 - 295
PURPOSE OF REVIEWThe derivation of signatures using -omics technologies is increasingly integrated in the design of clinical trials in oncology. In this... 
genomics | prognostic biomarker | clinical trials | predictive biomarker | signature | GENE-EXPRESSION SIGNATURE | PHASE-III | VALIDATION | MARKERS | BREAST-CANCER | BIOMARKERS | WOMEN | ONCOLOGY | END-POINTS | SUBGROUP | UTILITY | Breast Neoplasms - therapy | Neoplasms - metabolism | Neoplasms - therapy | Breast Neoplasms - genetics | Neoplasms - genetics | Humans | Female | Clinical Trials as Topic - methods | Clinical Trials as Topic - standards | Proteomics - methods | Genomics - methods | Breast Neoplasms - metabolism
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13. Full Text Recommendations for clinical trial development in follicular lymphoma
by Maddocks, Kami and Barr, Paul M and Cheson, Bruce D and Little, Richard F and Baizer, Lawrence and Kahl, Brad S and Leonard, John P and Fowler, Nathan and Gordon, Leo I and Link, Brian K and Friedberg, Jonathan W and Ansell, Stephen M
Journal of the National Cancer Institute, ISSN 0027-8874, 2017, Volume 109, Issue 3, p. djw255
Follicular lymphoma (FL) is the second most common lymphoid malignancy, representing 20% to 25% of all cases of nonHodgkin's lymphoma (NHL), and the most... 
1ST-LINE TREATMENT | GRADE 3B | ONCOLOGY | BONE-MARROW-TRANSPLANTATION | PHASE-III | TERM-FOLLOW-UP | NON-HODGKINS-LYMPHOMA | DES LYMPHOMES | RANDOMIZED CONTROLLED-TRIAL | CHOP PLUS RITUXIMAB | CHEMOTHERAPY | Lymphoma, Follicular - therapy | Prognosis | Humans | Treatment Outcome | Clinical Trials as Topic | Disease Progression | Patient Selection | Antineoplastic Combined Chemotherapy Protocols - therapeutic use | Lymphoma, Non-Hodgkin - therapy | Endpoint Determination | Biomarkers, Tumor - metabolism | Quality of Life | Research Design | Clinical trials | Lymphomas | Research | Analysis | Risk factors
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14. Full Text High level of soluble programmed cell death ligand 1 in blood impacts overall survival in aggressive diffuse large B-cell lymphoma: Results from a French multicenter clinical trial
by Rossille, D and Rossille, D and Gressier, M and Damotte, D and Maucort-Boulch, D and Pangault, C and Semana, G and Le Gouill, S and Haioun, C and Tarte, K and Lamy, T and Milpied, N and Fest, T and Damaj, G and Clavert, A and Al Jijakli, A and Banos, A and Dutel, J.-L and Deconinck, E and Rodon, P and Bouabdallah, K and Soubeyran, P and Choufi, B and Maakaroun, A and Tournilhac, O and Fleury, J and Gressin, R and Maisonneuve, H and Laribi, K and Solal-Celigny, P and Moreau, P and Rossi, J.-F and Cartron, G and Morineau, N and Harousseau, J.L and Jourdan, E and Alexis, M and Dreyfus, F and Delwail, V and Cornillon, J and Garidi, R and Gyan, E and Colombat, P and Godemer, P and Grp Ouest-Est Leucemies Autres Mal and Groupe Ouest-Est des Leucémies et Autres Maladies du Sang and for the Groupe Ouest-Est des Leucémies et Autres Maladies du Sang
Leukemia, ISSN 0887-6924, 12/2014, Volume 28, Issue 12, pp. 2367 - 2375
The dosage of soluble programmed cell death ligand 1 (sPD-L1) protein in the blood of adults with cancer has never been performed in a prospective patient... 
CONSOLIDATION | RITUXIMAB PLUS CYCLOPHOSPHAMIDE | ONCOLOGY | IMMUNOTHERAPY | R-CHOP | VINCRISTINE | DOXORUBICIN | MECHANISMS | HODGKIN-LYMPHOMA | HEMATOLOGY | EXPRESSION | CHEMOTHERAPY | Lymphoma, Large B-Cell, Diffuse - drug therapy | Prognosis | Follow-Up Studies | Lymphoma, Large B-Cell, Diffuse - pathology | Humans | Middle Aged | Male | Treatment Outcome | Disease Progression | Lymphoma, Large B-Cell, Diffuse - mortality | Young Adult | Clinical Trials, Phase III as Topic | B7-H1 Antigen - blood | Lymphoma, Large B-Cell, Diffuse - blood | Antineoplastic Combined Chemotherapy Protocols - therapeutic use | Adolescent | Intention to Treat Analysis | Adult | Female | France | Neoplasm Staging | Development and progression | Lymphomas | Genetic aspects | Blood diseases | Cell death | Life Sciences
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15. Full Text Clinical Trial and Registry Data
by Gooderham, Melinda and Papp, Kim
11/2017, Current Problems in Dermatology, ISBN 9783318061000, Volume 53, 13
Physicians rely on safety and efficacy data from pivotal trials to guide treatment decisions and manage patients. Even with robust clinical trial data, there... 
Chapter | Clinical Trials, Phase III as Topic | Psoriasis - drug therapy | Interleukin-17 - antagonists & inhibitors | Interleukin-23 - antagonists & inhibitors | Humans | Interleukin-12 - antagonists & inhibitors | Biological Products - adverse effects | Registries | Cytokines - antagonists & inhibitors | Dermatologic Agents - adverse effects | Infection - chemically induced | Tumor Necrosis Factor-alpha - antagonists & inhibitors
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16. Full Text Women on multiple sclerosis clinical trial steering committees
by Moneim, Joseph and Coles, Alasdair John and Giovannoni, Gavin and Horne, Rachel and Carr, Oliver
ISSN 0364-5134, 2018
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